PSMA PET to predict treatment response in advanced prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, observational multicenter registry will enroll patients with advanced prostate cancer (hormone-sensitive or castration-resistant) undergoing PSMA PET/CT before systemic treatment. Quantitative PSMA PET parameters — including lesion count, metabolic tumor volume (MTV), SUVmax, and SUVmean — will be measured and recorded across participating centers. Investigators will correlate these imaging biomarkers with clinical outcomes such as progression-free and overall survival and with response to a range of systemic therapies (abiraterone, enzalutamide, apalutamide, darolutamide, taxanes, PARP inhibitors, radiotherapy, and PSMA-directed radioligand therapy). Data collection is planned over approximately nine years to allow prospective longitudinal assessment and development of prognostic models.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histological diagnosis of advanced prostate cancer (excluding neuroendocrine carcinoma);
* Patients undergoing PSMA PET for pre-treatment disease staging;
* Candidates to receive one or more of the following systemic therapies, in combination or alone: abiraterone, enzalutamide, apalutamide, darolutamide, docetaxel, cabazitaxel, olaparib, radiotherapy, lutetium-177-PSMA, actinium-225-PSMA;
* Provision of signed informed consent for study participation and data handling.

Exclusion Criteria:

* Inability to remain supine and still for the PET/CT image acquisition;
* Prostate cancer with a known significant neuroendocrine component;
* Presence of another concurrent malignancy, with the exception of non-melanoma skin cancer.

Where it's running

• Nuclear Medicine, IRCCS Azienda Ospedaliero-Universitaria di Bologna
  Bologna, Italy, Italy Recruiting
• Azienda Ospedaliera Santa Croce e Carle - ospedale Santa Croce
  Cuneo, Italy, Italy Recruiting
• U.O. Medicina Nucleare, IRCCS Ospedale Policlinico San Martino
  Genova, Italy, Italy Recruiting
• UOC Medicina Nucleare, AOU Policlinico G.Martino
  Messina, Italy, Italy Recruiting

Study contacts

• Principal investigator: Andrea Farolfi — IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Study coordinator: Andrea Farolfi, MD
• Email: andrea.farolfi@aosp.bo.it
• Phone: +390512143959

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.